Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HN9
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised double-blind placebo controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Head and neck
Intervention
1. Group A: Active SSD pastille (Polymyxin E 2 mg, Tobramycin 1.8 mg and Amphotericin B 10 mg). Treatment to start on the day radiotherapy begins, one pastille four times daily until radiation reactions have settled.
2. Group B: Placebo pastille four times daily. Treatment to start on the first day of radiotherapy until radiation reactions have settled.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1999
Overall trial end date
31/12/2000
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with head and neck cancer receiving potentially curative doses of radiotherapy
2. Eligible patients may have squamous carcinoma, adenocarcinoma or salivary tumours arising in the oral cavity, nas -oro, or hypopharynx, larynx and paranasal sinuses
3. Stages T1-T4
4. No allergy to Polymyxin E, Tobramycin or Amphotericin B
5. No pre-existing oral or oropharyngeal infection
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1999
Recruitment end date
31/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Not defined
Funder name
Not available
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 1996 results in http://www.ncbi.nlm.nih.gov/pubmed/8688343
Publication citations
-
Results
Symonds RP, McIlroy P, Khorrami J, Paul J, Pyper E, Alcock SR, McCallum I, Speekenbrink AB, McMurray A, Lindemann E, Thomas M, The reduction of radiation mucositis by selective decontamination antibiotic pastilles: a placebo-controlled double-blind trial., Br. J. Cancer, 1996, 74, 2, 312-317.